Phase 1 Trial: Fortrea
| ISRCTN | ISRCTN40371122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40371122 |
| IRAS number | 1006698 |
| Secondary identifying numbers | IRAS 1006698 |
- Submission date
- 26/06/2024
- Registration date
- 27/06/2024
- Last edited
- 27/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Public, Scientific
3170 Porter Drive
Palo alto
94304
United States of America
| ClinicalTrialDisclosure@jazzpharma.com |
Principal Investigator
Drapers Yard, Marshall Street
Leeds
LS11 9EH
United Kingdom
| Phone | +441133013644 |
|---|---|
| jim.bush@fortrea.com |
Study information
| Study design | Phase I safety tolerability and pharmacokinetics in 96 healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Safety |
| Participant information sheet | Not available in web format |
| Scientific title | Phase 1 Trial: Fortrea |
| Study objectives | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Ethics approval(s) |
1. Approved 19/01/2023, London-Brent Research Ethic Committee (80 London Road, Skipton House, London, SE1 6LH, United Kingdom; +44 (0)20 3080 6456; brent_rec@hra.nhs.uk), ref: 22/LO/0850 2. Approved 07/03/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6456; clintrialhelpline@mhra.gov.uk), ref: CTA 36772/0031/001-0001 |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| Intervention | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacokinetic, Dose response |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Primary outcome measure | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Secondary outcome measures | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Overall study start date | 17/11/2022 |
| Completion date | 12/01/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 96 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key exclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 18/04/2023 |
| Date of final enrolment | 12/01/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Holbeck
Leeds
LS11 9EH
United Kingdom
Sponsor information
Industry
Building 730, Kent Science Park, Sittingbourne
Kent
ME9 8AG
United Kingdom
| ClinicalTrialDisclosure@jazzpharma.com |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 24/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this phase I study and the negligible benefit to the public of phase I information. Results will be posted on or after the date of publication of full trial details. |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of nontherapeutic clinical trials. |
Editorial Notes
27/06/2024: Study's existence confirmed by Health Research Authority (HRA) London-Brent Research Ethic Committee.
